Status:
COMPLETED
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
Lead Sponsor:
Organon and Co
Conditions:
Migraine, Acute
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.
Eligibility Criteria
Inclusion
- Patient weighs at least 20 kg (44 pounds)
- Patient has had a history of migraine with or without aura \> 6 months with \>= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
- Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
- Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
- Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
- The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and
- patient assent
- \- For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.
Exclusion
- Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
- Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
- Patient has basilar or hemiplegic migraine headaches
- Patient has \>15 headache-days per month OR has taken medication for acute
- headache on more than 10 days per month in any of the 3 months prior to screening
- Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any
- cancer, or any other significant disease
- Patient has a history or clinical evidence of cardiovascular problems or stroke
- Patient has either demonstrated hypersensitivity to or experienced a serious
- adverse event in response to rizatriptan
- Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
- Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
- Patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
- Patient is currently participating or has participated in a study with an
- investigational compound or device within 30 days of screening
- \- Patient is legally or mentally incapacitated.
Key Trial Info
Start Date :
November 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2011
Estimated Enrollment :
1382 Patients enrolled
Trial Details
Trial ID
NCT01001234
Start Date
November 30 2009
End Date
April 21 2011
Last Update
May 7 2024
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